The Pitt Center for Emergency Responder Wellness

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT05357586
Collaborator
(none)
60
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1
33.1
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Study Details

Study Description

Brief Summary

Emergency responders protect the public despite occupational hazards that threaten their mental health. The Pitt Center for Emergency Responder Wellness will be a clinical innovation hub that: 1) delivers accessible interventions for promoting mental health and overall wellbeing; 2) trains the next generation of students to provide mental health care for emergency responders; and 3) informs scientific understanding of post-trauma recovery processes. Goals for the seed phase are to establish our team and collect pilot data to demonstrate feasibility and initial clinical impact.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
N/A

Detailed Description

Emergency responders protect the public despite occupational hazards that threaten their mental health. This Center will be a clinical innovation hub that: 1) delivers accessible interventions for promoting mental health and overall wellbeing; 2) trains the next generation of graduate students to provide mental health care for emergency responders; and 3) informs scientific understanding of post-trauma recovery processes. Goals for the seed phase are to establish our team and collect pilot data to demonstrate feasibility and initial clinical impact. In this pilot study, the investigators will demonstrate feasibility by treating 30 eligible emergency responders (up to 60 total participants will be enrolled). The investigators will document treatment acceptability via treatment completion rates. The investigators will document treatment effects by measuring changes in mental health symptoms and quality of life. The investigators will disseminate our findings via conference presentations and manuscripts. The investigators will train graduate students in working with this specialized population.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single group, uncontrolled, pilot studySingle group, uncontrolled, pilot study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Serving Those Who Protect the Public: The Pitt Center for Emergency Responder Wellness
Actual Study Start Date :
Mar 29, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transdiagnostic cognitive behavioral therapy

Transdiagnostic cognitive behavioral therapy

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders is a manualized, evidence-based form of cognitive behavioral therapy aimed at targeting emotion regulation processes that underlie common forms of emotional disorders such as anxiety, depression, and commonly co-occurring mental health challenges.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline to post-treatment in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5) [The PCL-5 will be administered at baseline and post-treatment (up to 20 weeks).]

    Self-reported posttraumatic stress disorder (PTSD) symptom severity measured using the PCL-5. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.

  2. Change from baseline to follow-up in posttraumatic stress disorder (PTSD) symptom severity using the PTSD Checklist for DSM-5 (PCL-5) [The PCL-5 will be administered at baseline and follow-up (7 months post-baseline).]

    Self-reported posttraumatic stress disorder (PTSD) symptom severity measured using the PCL-5. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.

  3. Change from baseline to post-treatment in depressive symptom measured using the Patient Health Questionnaire-9 (PHQ-9) [The PHQ-9 will be administered at baseline and post-treatment (up to 20 weeks).]

    Self-reported depression symptom severity will be measured using the Patient Health Questionnaire 9 Item-Depression (PHQ-9). Scores range from 0-27, with higher scores indicating greater severity of depression symptoms.

  4. Change from baseline to follow-up in depressive symptoms measured using the Patient Health Questionnaire-9 (PHQ-9) [The PHQ-9 will be administered at baseline and follow-up (7 months post-baseline).]

    Self-reported depression symptom severity will be measured using the Patient Health Questionnaire 9 Item-Depression (PHQ-9). Scores range from 0-27, with higher scores indicating greater severity of depression symptoms.

  5. Change from baseline to post-treatment in anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7) [The GAD-7 will be administered at baseline and post-treatment (up to 20 weeks).]

    Self-reported depression symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21 with higher scores indicating greater anxiety symptom severity.

  6. Change from baseline to follow-up in anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7) [The GAD-7 will be administered at baseline and follow-up (7 months post-baseline).]

    Self-reported depression symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21 with higher scores indicating greater anxiety symptom severity.

  7. Change from baseline to post-treatment in alcohol misuse severity measured using the Alcohol Use Disorders Identification Test (AUDIT) [The AUDIT will be administered at baseline and post-treatment (up to 20 weeks).]

    Self-reported alcohol misuse measured using the Alcohol Use Disorders Identification Test (AUDIT). Scores range from 0-40 with higher scores indicating greater alcohol misuse.

  8. Change from baseline to follow-up in alcohol misuse severity measured using the Alcohol Use Disorders Identification Test (AUDIT) [The AUDIT will be administered at baseline and follow-up (7 months post-baseline).]

    Self-reported alcohol misuse measured using the Alcohol Use Disorders Identification Test (AUDIT). Scores range from 0-40 with higher scores indicating greater alcohol misuse.

Secondary Outcome Measures

  1. Change from baseline to post-treatment in functional impairment measured using the Work and Social Adjustment Scale (WSAS) [The WSAS will be administered at baseline and post-treatment (up to 20 weeks).]

    Self-reported functional impairment measured using the Work and Social Adjustment Scale (WSAS). Scores range from 0-8 with higher scores indicating more severe functional impairment.

  2. Change from baseline to follow-up in functional impairment measured using the Work and Social Adjustment Scale (WSAS) [The WSAS will be administered at baseline and follow-up (7 months post-baseline).]

    Self-reported functional impairment measured using the Work and Social Adjustment Scale (WSAS). Scores range from 0-8 with higher scores indicating more severe functional impairment.

  3. Change from baseline to post-treatment in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF). [The WHOQOL-BREF will be administered at baseline and post-treatment (up to 20 weeks).]

    Self-reported quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF). Scores range from 26 to 130 with higher scores indicating greater quality of life.

  4. Change from baseline to follow-up in quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF). [The WHOQOL-BREF will be administered at baseline and follow-up (7 months post-baseline).]

    Self-reported quality of life measured using the World Health Organization Quality of Life (WHOQOL-BREF). Scores range from 26 to 130 with higher scores indicating greater quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Participants will be age 18 or older.

  2. They will be emergency responders defined as fire fighters, law enforcement officers, emergency medical service personnel, emergency room medical providers (physicians, nurses, physician assistants), emergency dispatchers, and emergency response trainees who have completed training experiences in which they encountered emergencies.

  3. They must reside in Pennsylvania.

Exclusion Criteria:
  1. Are unable or unwilling to complete the study procedures.

  2. Receiving another form of therapy our counseling for anxiety, depression, posttraumatic stress, or alcohol use problems. Attendance at self-help programs (e.g., Alcoholics Anonymous) and couples therapy is permitted.

  3. Have a history of a psychotic disorder or bipolar disorder.

  4. Endorse drug use and symptoms consistent with a non-alcohol substance use disorder except nicotine, caffeine, or cannabis.

  5. Are experiencing a current suicidal or homicidal crisis warranting immediate intervention: potential participants may participate later once stabilized.

  6. Are currently awaiting the outcome of litigation involving their employment or training as emergency responders or any other reason deemed by the study team to be potentially related to their mental health.

  7. Evidence severe organic brain impairment as evidenced by a major apparent disruption of consciousness, cognition, speech, or behavior that would likely interfere with treatment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Pittsburgh Pennsylvania United States 15260

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

  • Study Director: Eric C Meyer, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eric Meyer, Professor, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT05357586
Other Study ID Numbers:
  • STUDY21120152
First Posted:
May 3, 2022
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2022